NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1826Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1826Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70771-1826-070771182600707711826001 BOTTLE, WITH APPLICATOR in 1 CARTON (70771-1826-0) / 10 mL in 1 BOTTLE, WITH APPLICATORMarketed from Apr 24, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Tavaborole
Generic name (nonproprietary)
tavaborole
Active ingredients
Tavaborole — 43.5 mg/mL
Dosage form
Solution
Route
Topical
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212294
Marketing start
Listing expires
Other FDA classes
Boron Compounds (Chemical structure)Protein Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 70771-1826_b7ea9baf-cd2b-4430-a0cf-85945ce38a17SPL ID b7ea9baf-cd2b-4430-a0cf-85945ce38a17SPL set ID 15bc62dc-4f5e-4d43-a125-d1f00bee84a5RxCUI 1543177UNII K124A4EUQ3
Pharmacologic class
Oxaborole Antifungal

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470771182600 followed by a unit qualifier and the quantity

Package 70771-1826-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1826

What is NDC 70771-1826?
70771-1826 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tavaborole.
What is the active ingredient?
Tavaborole.
Who is the labeler?
Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tavaborole?
6 other product NDCs are listed under this name. See all Tavaborole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tavaborole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalAlembic Pharmaceuticals Limited46708-46746708-0467-0446708-0467-10
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalViona Pharmaceuticals Inc72578-10272578-0102-04
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalChartwell RX, LLC62135-66362135-0663-59
tavaboroleTavaborole 43.5 mg/mLSolutionTopicalMayne Pharma Commercial LLC51862-690—
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalAlembic Pharmaceuticals Inc.62332-46762332-0467-0462332-0467-10
Tavaboroletavaborole topical solution, 5%Tavaborole 43.5 mg/mLSolutionTopicalEncube Ethicals, Inc.21922-02021922-0020-12

Other NDCs under ANDA 212294

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212294
ProductStrengthForm · routeLabelerProduct NDC
TavaboroleTavaborole 43.5 mg/mLSolutionTopicalViona Pharmaceuticals Inc72578-102

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